Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Interventions
Trade Name: TRIMBOW®
Product Name: TRIMBOW®
Pharmaceutical Form: Pressurised inhalation, solution
INN or Proposed INN: Beclometasone dipropionate
CAS Number: 5534-09-8
Current Sponsor code: SUB00681MI
Sponsors
Chiesi Farmaceutici S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with established diagnosis of COPD at least 12 months prior to the screening visit (according to GOLD Report, revised 2019). Patients with a diagnosis of Asthma COPD Overlap Syndrome (ACOS) and with a current diagnosis of atopy or allergic rhinitis based on their medical history and investigator judgement will be also eligible for inclusion. - Current smokers or ex-smokers, who quit smoking at least 6 months prior to screening visit, with a smoking history of at least 10 pack years [pack-years = (number of cigarettes per day x number of years)/20]. If patients underwent any kind of smoking cessation therapy, it should be finished at least 2 months prior to screening. - A post-bronchodilator FEV1 =65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
Exclusion criteria: - Diagnosis of asthma. - Patients requiring use of the following medications: i. A course of systemic steroids longer than 3 days for COPD exacerbation in the 4 weeks prior to screening. ii. A longer than 7-day course of antibiotics for the treatment of COPD exacerbation in the 4 weeks prior to screening. iii. Use of antibiotics for a lower respiratory tract infection (e.g pneumonia) in the 4 weeks prior to screening. - COPD exacerbation requiring prescriptions of systemic corticosteroids and/or antibiotics or hospitalization during the run-in period. - Patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia. - Known respiratory disorders other than COPD which may impact the efficacy of the study drug according the investigator’s judgment. This can include but is not limited to alfa-1 antitrypsin deficiency, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension and interstitial lung disease. - Patients who have clinically severe cardiovascular condition (such as but not limited to unstable ischemic heart disease, NYHA Class III/IV, left ventricular failure, acute myocardial infarction, not controlled arrhythmia etc.), which may impact the efficacy or the safety of the study drug according to the investigator’s judgement. - An abnormal and clinically significant 12-lead ECG which may impact the safety of the patient according to investigator’s judgement. Patients whose electrocardiogram (ECG) (12 lead) shows QTcF >450 ms for males or QTcF >470 ms for females at screening or at randomisation visits are not eligible. The QTcF criterion should not be applicable to patients with pacemaker or permanent atrial fibrillation. - Medical diagnosis of narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that in the opinion of the investigator would prevent use of anticholinergic agents. - History of hypersensitivity to anticholinergics, ß2-agonist, corticosteroids or any of the excipients contained in any of the formulations used in the trial which may raise contra-indications or impact the efficacy of the study drug according to the investigator’s judgement. - Clinically significant laboratory abnormalities indicating a significant or unstable concomitant disease which may impact the efficacy or the safety of the study drug according to investigator’s judgement. - Unstable concurrent disease: e.g. fever, uncontrolled hyperthyroidism, uncontrolled diabetes mellitus or other endocrine disease; significant hepatic impairment; significant renal impairment; uncontrolled gastrointestinal disease (e.g. active peptic ulcer); uncontrolled neurological disease; uncontrolled haematological disease; uncontrolled autoimmune disorders, or other which may impact the efficacy or the safety of the study drug according to investigator’s judgment. - History of alcohol abuse and/or substance/drug abuse within 12 months prior to screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To compare the effect of TRIMBOW® and RELVAR® on small airways restriction and lung stiffness with specific test measured 5-120 minutes post-dose after 4 weeks of treatment. • To compare the effect of TRIMBOW® and RELVAR® on other Forced Oscillation Technique (FOT) parameters used to assess the lung function • To compare the effect of TRIMBOW® and RELVAR® in terms of lung function parameters; • To compare the effect of TRIMBOW® and RELVAR® in terms of health status and COPD impact on patient health assessed through COPD Assessment Test (CAT); • To evaluate safety and tolerability of TRIMBOW® and RELVAR®. ;Secondary Objective: NA;Primary end point(s): Area under the curve of Reactance (AX) 5 - 120 minutes post-dose after 4 weeks of treatment with Trimbow and Relvar.;Timepoint(s) of evaluation of this end point: The AX will be measured as the average of 5, 15, 30, 60, 90 and 120 minutes post-dose assessments. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA | — |
Countries
United Kingdom
Contacts
Public ContactClinical Project Manager
CHIESI FARMACEUTICI S.p.A
Outcome results
None listed